Devices for inserting and expanding spinal implants

ABSTRACT

A driving instrument for adjusting a spinal implant includes an outer shaft having a distal end configured to actuate a proximal adjustment assembly of a spinal implant, and an inner shaft having a distal end configured to actuate a distal adjustment assembly of the spinal implant. The inner shaft is disposed within the outer shaft, with a proximal end of the inner shaft extending proximally from the outer shaft. The proximal end is configured to be rotated such that rotation of the inner shaft results in simultaneous rotation of the inner and outer shafts, with rotation of the outer shaft ceasing at a first value of resistance associated with the proximal adjustment assembly and rotation of the inner shaft ceasing at a second value of resistance associated with the distal adjustment assembly such that cessation of rotation of the inner shaft is independent from cessation of rotation of the outer shaft.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of the filing date of United StatesProvisional Patent Application No. 62/640,881 filed Mar. 9, 2018, thedisclosure of which is hereby incorporated herein by reference.

TECHNICAL FIELD

The present disclosure relates generally to orthopedic surgical devices,and more particularly, to devices for inserting, positioning, and/oradjusting expandable spinal implants and methods of using the same.

BACKGROUND

The spinal column is a complex system of bones and connective tissuesthat provide support for the human body and protection for the spinalcord and nerves. The adult spine includes an upper portion and a lowerportion. The upper portion contains twenty-four discrete bones, whichare subdivided into three areas including seven cervical vertebrae,twelve thoracic vertebrae, and five lumbar vertebrae. The lower portionincludes the sacral and coccygeal bones. The cylindrical shaped bones,called vertebrae or vertebral bodies, progressively increase in sizefrom the upper portion downwards to the lower portion.

An intervertebral disc along with two posterior facet joints cushion anddampen the various translational and rotational forces exerted upon thespinal column. The intervertebral disc is a spacer located between twovertebral bodies. The facets provide stability to the posterior portionof adjacent vertebrae. The spinal cord is housed in the canal of thevertebral bodies. It is protected posteriorly by the lamina. The laminais a curved surface with three main protrusions. Two transverseprocesses extend laterally from the lamina, while the spinous processextends caudally and posteriorly. The vertebral bodies and lamina areconnected by a bone bridge called the pedicle.

The spine is a flexible structure capable of a large range of motion.There are various disorders, diseases, and types of injury, whichrestrict the range of motion of the spine or interfere with importantelements of the nervous system. The problems include, but are notlimited to, scoliosis, kyphosis, excessive lordosis, spondylolisthesis,slipped or ruptured disc, degenerative disc disease, vertebral bodyfracture, and tumors. Persons suffering from any of the above conditionstypically experience extreme and/or debilitating pain, and often timesdiminished nerve function. These conditions and their treatments can befurther complicated if the patient is suffering from osteoporosis, orbone tissue thinning and loss of bone density.

Spinal discs between the endplates of adjacent vertebrae in a spinalcolumn of the human body provide critical support. However, due toinjury, degradation, disease, or the like, these discs can rupture,degenerate, and/or protrude to such a degree that the intervertebralspace between adjacent vertebrae collapses as the disc loses at least apart of its support function. This can cause impingement of the nerveroots and severe pain.

In some cases, surgical correction may be required. Some surgicalcorrections include the removal of the natural spinal disc from betweenthe adjacent vertebrae. In order to preserve the intervertebral discspace for proper spinal column function, an interbody spacer can beinserted between the adjacent vertebrae.

Typically, a prosthetic implant is inserted between the adjacentvertebrae and may include pathways that permit bone growth between theadjacent vertebrae until they are fused together. However, there existsa possibility that conventional prosthetic implants may be dislodged ormoved from their desired implantation location due to movement by thepatient before sufficient bone growth or fusion has occurred. Due to theconcave nature of the vertebral body endplates, it can be challenging toobtain enough contact between the implant and the endplates to createbone growth. Additionally, achieving the desired lordosis can bedifficult given the limitation of typical prosthetic implants once theyare implanted.

Therefore, a need exists for systems that maximize contact of spinalimplants with the vertebral body endplates such that a spinal implantmatches the desired amount of lordosis, allows for bone growth betweenadjacent vertebrae, maintains the space between adjacent vertebraeduring bone ingrowth, and/or resists dislocation from its implantationsite.

SUMMARY

In accordance with an aspect of the present disclosure, a drivinginstrument for adjusting a spinal implant includes an outer shaft and aninner shaft. The outer shaft includes a distal end configured to actuatea proximal adjustment assembly of a spinal implant, and the inner shaftincludes a distal end configured to actuate a distal adjustment assemblyof the spinal implant. The inner shaft is disposed within the outershaft, with a proximal end of the inner shaft extending proximally fromthe outer shaft. The proximal end is configured to be rotated such thatrotation of the inner shaft results in simultaneous rotation of theinner and outer shafts, with rotation of the outer shaft ceasing at afirst value of resistance associated with the proximal adjustmentassembly and rotation of the inner shaft ceasing at a second value ofresistance associated with the distal adjustment assembly such thatcessation of rotation of the inner shaft is independent from cessationof rotation of the outer shaft.

In accordance with another aspect of the present disclosure, a systemfor implanting a spinal implant into a disc space between adjacentvertebral bodies includes a spinal implant and a driving instrument. Thespinal implant includes proximal and distal adjustment assemblies thatare independently operable to change a height of the proximal or distalregion, respectively, of the spinal implant. The driving instrumentincludes an outer shaft and an inner shaft. The outer shaft includes adistal end configured to actuate the proximal adjustment assembly of thespinal implant, and the inner shaft includes a distal end configured toactuate the distal adjustment assembly of the spinal implant. The innershaft is disposed within the outer shaft, with a proximal end of theinner shaft extending proximally from the outer shaft. The proximal endis configured to be rotated such that rotation of the inner shaftresults in simultaneous rotation of the inner and outer shafts toactuate both the proximal and distal adjustment assemblies, withrotation of the outer shaft ceasing at a first value of resistanceassociated with the proximal adjustment assembly and rotation of theinner shaft ceasing at a second value of resistance associated with thedistal adjustment assembly such that cessation of rotation of the innershaft is independent from cessation of rotation of the outer shaft.

In accordance with yet another aspect of the present disclosure, amethod of implanting a spinal implant into a disc space between adjacentvertebral bodies includes: inserting a driving instrument intoengagement with a spinal implant disposed within a disc space, thedriving instrument including: an outer shaft including a distal endconfigured to actuate a proximal adjustment assembly of a spinalimplant; and an inner shaft disposed within the outer shaft, the innershaft including a distal end configured to actuate a distal adjustmentassembly of the spinal implant and a proximal extending proximally fromthe outer shaft; and rotating the inner shaft of the driving instrumentto simultaneously rotate both the inner and outer shafts to actuate boththe proximal and distal adjustment assemblies.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosureand, together with a general description of the disclosure given above,and the detailed description of the embodiments given below, serve toexplain the principles of the disclosure, wherein:

FIG. 1 is a perspective view, with parts separated, of a spinal implantand a set screw in accordance with an embodiment of the presentdisclosure;

FIG. 2 is a side cross-sectional view of the spinal implant and the setscrew of FIG. 1;

FIG. 3 is an exploded view of the spinal implant of FIG. 1;

FIG. 4 is a perspective view of a system including the spinal implant ofFIG. 1 and an insertion instrument in an open configuration, inaccordance with an embodiment of the present disclosure;

FIG. 5A is a side view of the insertion instrument of FIG. 4;

FIG. 5B is a cross-sectional view of the insertion instrument of FIG.5A, taken along section line 5B-5B of FIG. 5A;

FIG. 6A is a perspective view of the system of FIG. 4, with theinsertion instrument in the open position and the spinal implant alignedwith the insertion instrument;

FIG. 6B is a close-up view of the area of detail indicated in FIG. 6A;

FIG. 7A is a perspective view of the system of FIG. 4, with theinsertion instrument in a closed position and the spinal implantreleasably secured to the insertion instrument;

FIG. 7B is a close-up view of the area of detail indicated in FIG. 7A;

FIG. 8 is a perspective view of a system including the spinal implantand the insertion instrument of FIG. 4, and an insertion shaft inaccordance with an embodiment of the present disclosure;

FIG. 9A is a side view of the system of FIG. 8;

FIG. 9B is a cross-sectional view of the system of FIG. 9A, taken alongsection line 9B-9B of FIG. 9A;

FIG. 10 is a perspective view of a system including the spinal implantof FIG. 1 and a driving instrument in accordance with an embodiment ofthe present disclosure;

FIG. 11 is an exploded view of the driving instrument of FIG. 10;

FIG. 12A is a side view of the driving instrument of FIG. 10, in aheight adjusting position;

FIG. 12B is a cross-sectional view of the driving instrument of FIG.12A, taken along section line 12B-12B of FIG. 12A;

FIG. 13A is a side view of the driving instrument of FIG. 10, in aposterior adjusting position;

FIG. 13B is a cross-sectional view of the driving instrument of FIG.13A, taken along section line 13B-13B of FIG. 13A;

FIG. 14A is a side view of the driving instrument of FIG. 10, in alordosis adjusting position;

FIG. 14B is a cross-sectional view of the driving instrument of FIG.14A, taken along section line 14B-14B of FIG. 14A;

FIG. 15 is a perspective view of a system including the insertioninstrument of FIG. 4, the spinal implant of FIG. 1, and the drivinginstrument of FIG. 10;

FIG. 16 is a perspective view of the system of FIG. 15;

FIG. 17A is a side view of the system of FIG. 16;

FIG. 17B is a cross-sectional view of the system of FIG. 17A, takenalong section line 17B-17B of FIG. 17A;

FIG. 17C is a close-up view of the area of detail indicated in FIG. 17B;

FIG. 18A is a side view of the system of FIG. 16, with a button of theinsertion instrument compressed into a handle of the insertioninstrument;

FIG. 18B is a cross-sectional view of the system of FIG. 18A, takenalong section line 18B-18B of FIG. 18A;

FIG. 19 is a perspective view of a system including the spinal implantof FIG. 1 and a driving instrument in accordance with another embodimentof the present disclosure;

FIG. 20 is an exploded view of the driving instrument of FIG. 19;

FIG. 21A is a side view of the driving instrument of FIG. 19;

FIG. 21B is a cross-sectional view of the driving instrument of FIG.21A, taken along section line 21B-21B of FIG. 21A;

FIG. 22 is a perspective view of a system including the spinal implantand the insertion instrument of FIG. 4, and a set screw driver inaccordance with another embodiment of the present disclosure;

FIG. 23A is a side view of a sleeve in accordance with an embodiment ofthe present disclosure;

FIG. 23B is a top view of the sleeve of FIG. 23A;

FIG. 23C is an end view of the sleeve of FIG. 23A;

FIG. 24A is a side view of a system including the spinal implant and theinsertion instrument of FIG. 4, and the sleeve of FIG. 23A in accordancewith an embodiment of the present disclosure;

FIG. 24B is a top view of the system of FIG. 24A; and

FIG. 24C is an end view of the system of FIG. 24A.

DETAILED DESCRIPTION

Embodiments of the present disclosure are now described in detail withreference to the drawings in which like reference numerals designateidentical or corresponding elements in each of the several views. Theterm “clinician” refers to a doctor (e.g., a surgeon), a nurse, or anyother care provider, and may include support personnel. Throughout thisdescription, the term “proximal” refers to a portion of a system,device, or component thereof that is closer to a clinician, and the term“distal” refers to the portion of the system, device, or componentthereof that is farther from the clinician.

Referring now to the drawings, FIG. 1 illustrates an embodiment of anexpandable spinal implant or a spinal implant 100 for use in a system ofthe present disclosure. Spinal implant 100 has a proximal region 100 aand a distal region 100 b extending along a longitudinal axis “X.” Thespinal implant 100 includes an upper body 110 and a lower body 130disposed in opposed relation relative to each other and coupled togetherby a proximal adjustment assembly 150 and a distal adjustment assembly170. The proximal and distal adjustment assemblies 150, 170 areindependently operable or movable to allow for adjustment in the angularrelationship and vertical distance between the upper and lower bodies110, 130 of the proximal and/or distal regions 100 a, 100 b of thespinal implant 100 to achieve a desired configuration of the spinalimplant 100.

The spinal implant 100 is movable between a collapsed configuration(e.g., a minimum distance at which the upper and lower bodies 110, 130may be positioned relative to each other) and a fully expandedconfiguration (e.g., a maximum distance at which the upper and lowerbodies 110, 130 may be positioned relative to each other), and includesa number of partially expanded configurations. The desired configurationof the spinal implant 100 may be locked in place via a set screw 190that is engageable with the proximal and distal adjustment assemblies150, 170.

As shown in FIGS. 2 and 3, in conjunction with FIG. 1, the proximaladjustment assembly 150 includes a linkage body 152, a drive nut orflange nut 154 positionable within the linkage body 152, and a coupler156 disposed distally of the linkage body 152. The linkage body 152 andthe coupler 156 are sized and shaped to engage, and be supported on, ashaft 184 of an expander 174 of the distal adjustment assembly 170. Thelinkage body 152 includes a threaded inner surface 153 configured tomate with a threaded outer surface 192 of the set screw 190, and a pairof arms 158 extending along lateral sides of the linkage body 152. Thepair of arms 158 includes proximal cavities 158 a that are dimensionedto engage an insertion instrument 200 (see e.g. FIG. 4) and distal holes158 b that are aligned with, and coupled to, angled slots 120 a, 140 aof proximal fins 120, 140 of the upper and lower bodies 110, 130 via afirst set of pins 157 to adjustably couple the upper and lower bodies110, 130 together. The coupler 156 includes nubs 160 extending laterallytherefrom that are aligned with, and coupled to, vertical slots 120 b,140 b of the proximal fins 120, 140 of the upper and lower bodies 110,130.

The flange nut 154 has a threaded opening 163 defined therethrough thatis configured to threadably engage a drive screw or threaded post 172 ofthe distal adjustment assembly 170, and a shaped outer surface 165configured to mate with a driving instrument 300, 400 (see e.g., FIGS.10 and 19, respectively) such that either the flange nut 154 of thethreaded post 172 may be rotated and axially translated with respect tothe other. The flange nut 154 includes a distal flange 166 dimensionedto be received within the linkage body 152 such that movement of theflange nut 154 results in movement of the linkage body 152.

Accordingly, movement of the flange nut 154 distally moves the linkagebody 152 distally causing the first set of pins 157 to translate withinthe angled slots 120 a, 140 a of the proximal fins 120, 140 and the nubs160 of the coupler 156 to translate within the vertical slots 120 b, 140b of the proximal fins 120, 140 to increase the distance between theupper and lower bodies 110 and 130 in the proximal region 100 a of thespinal implant 100. Conversely, movement of the flange nut 154proximally moves the linkage body 152 proximally to reduce the distancebetween the upper and lower bodies 110, 130 in the proximal region 100 aof the spinal implant 100.

With continued reference to FIGS. 1-3, the distal adjustment assembly170 includes the threaded post 172, the expander 174, and a pivotlinkage assembly 175 including an upper pivot linkage 176, a lower pivotlinkage 178, and a connector linkage 180. The threaded post 172 includesan elongated threaded body 172 a having a recessed proximal end 172 bconfigured to mate with a driving instrument 300, 400 (see e.g., FIGS.10 and 19, respectively) and a distal end 172 c disposed within a recess183 of the connector linkage 180. The recessed proximal end 172 b mayhave a hex feature, e.g., hexagonal or hexolobular in shape, or anyother suitable configuration that is engageable with a suitable drivinginstrument to enable the driving instrument to control the insertionand/or advancement, as well as retraction and/or withdrawal, of thethreaded post 172 within the spinal implant 100.

The upper pivot linkage 176 is pivotably coupled to the upper body 110(e.g., about a second set of pins 186), and the lower pivot linkage 178is pivotably coupled to the lower body 130 (e.g., about a pin 187).Holes 177, 179, 181 of the upper pivot linkage 176, the lower pivotlinkage 178, and the connector linkage 180, respectively, are alignedwith each other and with longitudinal slots 185 defined in the expander174, and a pin 188 is disposed therethrough for pivotably securing theupper and lower bodies 110 and 130 to the expander 174 of the distaladjustment assembly 170 via the pivot linkage assembly 175.

Accordingly, rotation of the threaded post 172 in a first directionadvances the threaded post 172 distally through the flange nut 154 andthe shaft 184 of the expander 174 which, in turn, pushes the connectorlinkage 180 distally and drives the upper and lower pivot linkages 176,178 against a double ramped inner surface 182 of the expander 174thereby increasing the height between the upper and lower bodies 110,130 at the distal region 100 b of the spinal implant 100. Rotation ofthe threaded post 172 in a second, reverse direction moves the threadedpost 172 proximally which, in turn, moves the connector linkage 180proximally to allow the upper and lower pivot linkages 176, 178 tocollapse, thereby decreasing the height between the upper and lowerbodies 110, 130 at the distal region 100 b of the spinal implant 100.

For a detailed description of the structure and function of exemplaryspinal implants suitable for use in a system of the present disclosure,reference may be made to commonly owned U.S. patent application Ser. No.15/657,796, filed Jul. 24, 2017, and U.S. Patent Appl. Pub. No.2016/0166396, each entitled “Expandable Spinal Implants,” the entirecontents of each of which are incorporated herein by reference.

With reference now to FIGS. 4-5B, a system 1 including an insertioninstrument 200 for inserting and/or positioning the spinal implant 100into an intervertebral disc space is shown. The insertion instrument 200includes, from proximal to distal, a handle 210, a body portion 220, anda connector assembly 230 extending along a longitudinal axis “Y” that iscoincident with the longitudinal axis “X” (FIG. 1) of the spinal implant100. A lumen 201 is defined through the insertion instrument 200 (i.e.,the handle 210, the body portion 220, and the connector assembly 230)and configured to receive a tool (see e.g., the insertion shaft 250 ofFIG. 8 or the driving instruments 300, 400 of FIGS. 10 and 19,respectively), as described in detail below.

The handle 210 of the insertion instrument 200 includes a grip portion212 and a button 214. The button 214 includes a body 214 a disposedwithin the handle 210 and a pad 214 b extending laterally through thehandle 210. A pin 215 is secured to the handle 210 and extends into anelongated hole 217 of the button 214 such that the button 214 is movablerelative to the handle 210. The button 214 is biased towards a firstposition by a spring 216 (e.g., a wave spring) disposed within thehandle 210 such that a slot 219 defined through the body portion 214 aof the button 214 is axially misaligned with the lumen 201 to retain atool (not shown) therein. The button 214 is depressible into a secondposition that aligns the slot 219 with the lumen 201 to facilitateremoval of a tool therefrom.

The body portion 220 includes an elongated shaft 222, elongated rails224 slidably movable along tracks 226 disposed on opposed sides of theelongated shaft 222, and a rotation knob 228 disposed about a proximalportion 222 a of the elongated shaft 222. The rotation knob 228 includesa threaded inner surface 228 a that is threadably engaged with theproximal portion 222 a of the elongated shaft 222, and a distal recess228 b defined in the inner surface 228 a that is configured to receive aproximal flange 225 a of a proximal rod 225 configured to move theelongated rails 224 longitudinally. A distal flange 225 b of theproximal rod 225 is engaged with a proximal holes 224 a defined in theelongated rails 224. A distal rod 227 is disposed within the tracks 226,adjacent to, and longitudinally aligned with the proximal rod 225, andextends distally towards cover plates 236 of the elongated rails 224.

The connector assembly 230 includes connector arms 232 pivotally securedto opposed sides of the elongated shaft 222 of the body portion 220 viapivot pins 234. The cover plates 236 of the elongated rails 224 areslidably disposed over the connector arms 232. Each of the connectorarms 232 includes a proximal portion 232 a and a distal portion 232 bthat are disposed at angles with respect to the longitudinal axis “Y” ofthe insertion instrument 200. The proximal portion 232 a of eachconnector arm 232 includes a protrusion 238 on an outer surface thereof,and the distal portion 232 b of each connector arm 232 includes anengagement feature 240 (e.g., a hook) on an inner surface thereof.

The cover plates 236 each include a u-shaped body configured to engageand ride longitudinally along the tracks 226 of the elongated shaft 222.Each of the cover plates 236 includes a proximal hole 236 a engaged witha pin 237 disposed distal to the distal rod 227, and a distal opening236 b configured to receive the respective protrusion 238 of theconnector arms 232 when the connector arms 232 are disposed in a closedor grasping position.

As shown in FIGS. 6A and 6B, when the rotation knob 228 of the insertioninstrument 200 is disposed in a proximal position, the elongated rails224 are also disposed in a proximal position. In the proximal position,the cover plates 236 are disposed over the proximal portions 232 a ofthe connector arms 232 such that the proximal portions 232 a aresubstantially aligned with the longitudinal axis “Y” of the insertioninstrument 200, and the distal portions 232 b of the connector arms 232extend radially outward relative to the longitudinal axis “Y”. In theproximal position, the connector arms 232 are in an open position suchthat the spinal implant 100 may be placed adjacent the connectorassembly 230 of the insertion instrument 200, with the proximal cavities158 a of the linkage body 152 of the surgical implant 100 aligned withthe engagement features 240 of the insertion instrument 200.

As shown in FIGS. 7A and 7B, the rotation knob 228 of the insertioninstrument 200 may be moved to a distal position by rotating therotation knob 228 in a first direction which causes a correspondinglongitudinal movement of the elongated rails 224 along the tracks 226 ofthe elongated shaft 222. The distal movement of the connector plates 236over the connector arms 232 causes the connector arms 232 to pivot aboutthe pivot pins 234 (FIG. 5B) such that the distal portions 232 b of theconnector arms 232 are substantially aligned/parallel with thelongitudinal axis “Y” of the insertion instrument 200 and the proximalportions 232 a of the connector arms 232 extend radially outwardly suchthat the protrusions 238 are deflected into the distal openings 236 b ofthe connector plates 236. In the distal position, the connector arms 232are in a closed or grasping position and the engagement features 240 ofthe insertion instrument 200 are engaged with the proximal cavities 158a of the spinal implant 100 thereby releasably securing the insertioninstrument 200 to the spinal implant 100.

With reference now to FIG. 8, a system 2 includes an insertion shaft 250positionable within the insertion instrument 200 to aid in aligning andsecuring the spinal implant 100 to the insertion instrument 200 duringinsertion and/or positioning of the spinal implant 100 into anintervertebral disc space. The insertion shaft 250 includes an elongatebody 252 having a head 254 disposed at a proximal end thereof and athreaded tail 256 disposed at a distal end thereof.

As shown in FIGS. 9A and 9B, the insertion shaft 250 is inserted intothe lumen 201 of the insertion instrument 200 such that the threadedtail 256 is engaged with the threaded inner surface 153 (FIG. 1) of thelinkage body 152 of the spinal implant 100 and the head 254 abuts aproximal end of the handle 210. The head 254 includes a grooved outersurface 254 a and a partially threaded inner surface 254 b. The groovedouter surface 254 a is engageable with a tool (not shown) configured torotate the insertion shaft 250 and the partially threaded inner surface254 b is engageable with a driver (not shown) insertable through theinsertion shaft 250.

With the insertion shaft 250 disposed within the insertion instrument200, the slot 219 of the button 214 is out of alignment with the lumen201 of the insertion instrument 200 to hold the insertion shaft 250therein. To release the insertion shaft 250 from the insertioninstrument 200, the button 214 is pushed into the handle 210 to alignthe slot 219 of the button 214 with the lumen 201.

Turning now to FIGS. 10 and 11, a system 3 including a drivinginstrument 300 for driving the expansion and/or contraction of thespinal implant 100 is shown. The driving instrument 300 includes anouter shaft 310, a distal inner shaft 320, and a proximal shaft assembly330. The outer shaft 310 defines a lumen 311 therethrough, and includesa proximal base portion 312 and an elongated body portion 314terminating at an open tip 316. The open tip 316 includes an innersurface 316 a (see e.g., FIG. 12B) that is complementary in shape withthe shaped outer surface 165 (see e.g., FIG. 2) of the flange nut 154 ofthe spinal implant 100 to engage the flange nut 154.

The distal inner shaft 320 includes a proximal base portion 322 and anelongated body portion 324 terminating at a distal tip 326. The proximalbase portion 322 is disposed within the proximal base portion 312 of theouter shaft 310, and the elongated body 324 is disposed within theelongated body portion 314 of the outer shaft 310. The distal tip 326 isa male connector having a complementary geometry to the recessedproximal end 172 b (see e.g., FIG. 2) of the threaded post 172 (e.g., ahex feature) of the spinal implant 100 such that the distal tip 326 isreceivable therein and configured to engage the threaded post 172.

A spring 321 and a bushing 323 are inserted over the distal inner shaft320, distal to the proximal base portion 322 of the distal inner shaft320 and within a distal portion of the proximal base portion 312 of theouter shaft 310. The spring 321 is at least partially retained withinthe bushing 323. A bearing assembly 325 is also inserted over the distalinner shaft 320. The bearing assembly 325 includes a bearing retainer325 a having a ball bearings 325 b positioned therein, and end plates327 positioned on opposing sides of the bearing retainer 325 a. The endplates 327 each include an annular grooved surface 327 a facing thebearing retainer 325 a thereby providing a track to support and maintainthe position of the ball bearings 325 b such that the ball bearings 325b run smoothly therebetween and freely within the bearing retainer 325a.

A connector 329 is also disposed within the proximal base portion 312 ofthe outer shaft 310, proximal to the proximal base portion 322 of thedistal inner shaft 320. The connector 329 includes pockets 329 a definedtherethrough, as described in further detail below.

The proximal shaft assembly 330 includes a proximal outer shaft 332, aproximal inner shaft 334, and an adjustment knob 336. The proximal outershaft 332 is configured to be slidably disposed within the connector 329and the proximal base portion 322 of the distal inner shaft 320, whichare each disposed within the outer shaft 310, as described above. Afirst set of pins 331 is inserted through the proximal base portion 322of the distal inner shaft 320 along a distal groove 332 b defined aroundthe proximal outer shaft 332, and a second set of pins 333 is insertedthrough the proximal base portion 312 of the outer shaft 310 and theconnector 329.

The proximal outer shaft 332 includes proximal and distal ball bearingassemblies 342 a, 342 b disposed therein. The proximal inner shaft 334is slidably disposed within the proximal outer shaft 332, retaining theproximal and distal ball bearing assemblies 342 a, 342 b therebetween.The adjustment knob 336 is slidably disposed over the proximal outershaft 332. Plunger assemblies 338 are positioned in lateral sideopenings 336 a of the adjustment knob 336. Each plunger assembly 338includes a ball 338 a, a spring 338 b, and a screw 338 c retaining theball and spring 338 a, 338 b within the adjustment knob 336 adjacent tothe proximal outer shaft 332. The balls 338 are configured to engagerecesses 337 defined in the proximal outer shaft 332 upon actuation ofthe adjustment knob 336 between a height adjusting position “H” (FIGS.12A and 12B), a posterior or proximal adjusting position “P” (FIGS. 13Aand 13B), and a lordosis, anterior, or distal adjusting position “L”(FIGS. 14A and 14B). A pin 340 extends through opposed openings 336 b ofthe adjustment knob 336, a longitudinal opening 332 a defined in theproximal outer shaft 332, and an opening 334 c defined through theproximal inner shaft 334. Accordingly, the adjustment knob 336 may beslid between the height adjusting position “H” (FIGS. 12A and 12B), theproximal adjusting position “P” (FIGS. 13A and 13B), and the distaladjusting position “L” (FIGS. 14A and 14B) relative to the proximalouter shaft 332 which, in turn, causes a corresponding longitudinalmovement of the proximal inner shaft 334.

Proximal and distal recessed grooves 334 a, 334 b defined around theproximal inner shaft 332 and the pockets 329 a of the connector 329 areconfigured to engage/disengage the proximal and/or distal ball bearingassemblies 342 a, 342 b disposed within the proximal outer shaft 332during actuation of the adjustment knob 336 between the height,proximal, and distal adjusting positions to effect the function of thedriving instrument 300. Specifically, the proximal and distal ballbearing assemblies 324 a, 342 b are configured to float above or belowthe proximal outer shaft 332 to actively engage or disengage the distalinner shaft 320 and/or the outer shaft 310.

As shown in FIGS. 12A and 12B, when the adjustment knob 336 is in theheight adjusting position “H”, the proximal and distal ball bearingassemblies 342 a, 342 b are disengaged from the proximal and distalrecessed grooves 334 a, 334 b (FIG. 11) of the proximal inner shaft 334,as well as the pockets 329 a (FIG. 11) of the connector 329.Accordingly, actuation of the proximal outer shaft 332 of the proximaladjustment assembly 330 allows both the outer shaft 310 and the distalinner shaft 320 to be actuated such that the proximal and distaladjustment assemblies 150, 170 (see e.g., FIG. 1) of the spinal implant100 are simultaneously adjusted.

When the adjustment knob 336 is moved to the posterior adjustingposition “P”, as shown in FIGS. 13A and 13B, the proximal inner shaft334 is slid proximally such that the proximal ball bearing assembly 342a is disengaged from the proximal inner shaft 334 and the distal ballbearing assembly 342 b is engaged with the pocket 329 a of the connector329. Accordingly, actuation of the proximal outer shaft 332 of theproximal adjustment assembly 330 causes only the outer shaft 310 to beactuated such that only the proximal region 110 a of the spinal implant100 is actuated.

When the adjustment knob 336 is moved to the lordosis adjusting position“L”, as shown in FIGS. 14A and 14B, the proximal inner shaft 334 is sliddistally such that the proximal ball bear assembly 342 a is engaged withthe proximal recessed groove 334 c of the proximal inner shaft 334 andthe distal ball bearing assembly 342 b is disengaged from the pockets329 a of the connector 329. Accordingly, actuation of the proximal outershaft 332 of the proximal adjustment assembly 330 causes only the distalinner shaft 320 to be actuated such that only the distal region 110 b ofthe spinal implant 100 is actuated.

With reference now to FIGS. 15 and 16, a system 4 includes the drivinginstrument 300 positionable within the insertion instrument 200 to drivethe expansion or contraction of the spinal implant 100. As shown inFIGS. 17A-17C, with the connector arms 232 of the insertion instrument200 engaged with the proximal cavities 158 a of the spinal implant 100,the driving instrument 300 is inserted into the insertion instrument 200such that the open tip 316 and the distal tip 326 of the outer anddistal inner shafts 310, 320, respectively, of the driving instrument300 are engaged with the respective flange nut 154 and threaded post 172of the spinal implant 100. While the driving instrument 300 is shown inthe lordosis adjusting position “L”, such that only the distal innershaft 320 is rotated upon actuation of the driving instrument 300 (e.g.,to accommodate for lordosis), it should be understood that the drivinginstrument 300 may be used in any of the positions described above.After the spinal implant 100 is adjusted to a desired configuration, thedriving instrument 300 may be removed from the insertion instrument 200by pressing the button 214 of the handle 210 of the insertion instrument200, as shown in FIGS. 18A and 18B, to align the slot 219 of the button214 with the lumen 201 of the insertion instrument 200, and pulling thedriving instrument 300 proximally therefrom.

Turning now to FIGS. 19 and 20, a system 5 including a drivinginstrument 400 for driving the expansion and/or contraction of thespinal implant 100 is shown. The driving instrument 400 includes anouter shaft 410 and an inner shaft 420. The outer shaft 410 defines alumen 411 therethrough, and includes a proximal base portion 412 and anelongated body portion 414 terminating at an open tip 416. The open tip416 includes an inner surface 416 a that is complementary in shape withthe shaped outer surface 165 (see e.g., FIG. 2) of the flange nut 154 ofthe spinal implant 100 to engage the flange nut 154.

The inner shaft 420 includes a proximal portion 422, an elongated bodyportion 424 terminating at a distal tip 426, and a tapered portion 423interconnecting the proximal and elongated body portions 422, 424. Theproximal portion 422 has a collared section 422 a having an outerdimension complementary in size and shape with an inner surface of theproximal base portion 412 of the outer shaft 410. The distal tip 426 isa male connector having a complementary geometry to the recessedproximal end 172 b (see e.g., FIG. 2) of the threaded post 172 (e.g., ahex feature) such that the distal tip 426 is receivable therein andconfigured to engage the threaded post 172.

As shown in FIGS. 21A and 21B, in conjunction with FIG. 20, the proximalportion 422 of the inner shaft 420 is disposed within the proximal baseportion 412 of the outer shaft 410 and extends proximally therefrom suchthat a proximal end 422 b can be engaged with a tool (not shown) todrive rotation of the driving instrument 400. The elongated body 424 ispartially disposed within the proximal base portion 412 of the outershaft 410 and extends distally within the elongated body portion 414 ofthe outer shaft 410. A connector 429 is disposed within a proximalportion of the proximal base portion 412 of the outer shaft 410, and issecured therein via pins 413.

A spring 421 and a bushing 423 are inserted over the inner shaft 420,within a distal portion of the proximal base portion 412 of the outershaft 410. The spring 421 is at least partially retained within thebushing 423. A bearing assembly 425 is also inserted over the innershaft 420, adjacent to the bushing 423 and within the proximal baseportion 412 of the outer shaft 410. The bearing assembly 425 includes abearing retainer 425 a having ball bearings 425 b positioned therein,and end plates 427 positioned on opposing sides of the bearing retainer425 a. The end plates 427 each include an annular grooved surface 427 afacing the bearing retainer 425 a thereby providing a track to supportand maintain the position of the ball bearings 425 b such that the ballbearings 425 b run smoothly therebetween and freely within the bearingretainer 426 a. Rotation of the inner shaft 420 results in acorresponding rotation of the bearing assembly 425.

Actuation of the inner shaft 420 rotates both the outer shaft 410 andthe inner shaft 420 such that the proximal and distal adjustmentassemblies 150, 170 (see e.g., FIG. 1) of the spinal implant 100 aresimultaneously adjusted. When the outer shaft 410 meets a first value ofresistance associated with the proximal adjustment assembly 150 (e.g.,resistance due to the proximal region 100 a of the spinal implant 100contacting endplates of the vertebral bodies), the outer shaft 410 willstop rotating while the inner shaft 420 continues to rotate until theinner shaft 420 meets a second value of resistance associated with thedistal adjustment assembly 170 (e.g., resistance due to the distalregion 100 b of the spinal implant 100 contacting the endplates of thevertebral bodies). Accordingly, the driving instrument 400 expands thespinal implant 100 to a configuration that fills the intervertebral discspace.

The simultaneous, yet independent, adjustability of the proximal anddistal regions 100 a, 100 b of the spinal implant 100 with the drivinginstrument 400 allows a clinician to adjust the dimensions of the spinalimplant 100 (i.e., vertical heights of the proximal and distal regions)to partially or fully expanded positions so that the upper and lowerbodies 110, 130 are aligned with the endplates to maximize surfacecontact between the spinal implant 100 and the endplates, and to matchthe dimensions of the disc space defined between the endplates in whichthe spinal implant 100 is disposed, without force, to avoid trauma tothe vertebral bodies, and in particular, the endplates of the vertebralbodies.

The driving instrument 400 may be utilized in a system including theinsertion instrument 200 and the spinal implant 100 in a similar mannerdiscussed above with regard to the driving instrument 300.

An exemplary method of inserting, positioning, and/or adjusting (e.g.,expanding) the spinal implant 100 in a disc space between adjacentvertebral bodies with the insertion instrument 200 and the drivinginstrument 300, 400 will now be described. A clinician removes all or aportion of a disc from between two vertebral bodies (e.g., complete orpartial diskectomy), and scrapes and cleans the endplates of thevertebral bodies to prepare the surfaces for placement of the spinalimplant 100 such that a fusion will occur. Next, the clinician placesthe spinal implant 100 into the disc space using the insertioninstrument 200, alone or in combination with the insertion shaft 250, byaligning and releasably securing the connector assembly 230 of theinsertion instrument 200 to the spinal implant 100, as described above.The insertion instrument 200, and optionally the insertion shaft 250,may be pre-attached to the spinal implant 100 prior to inserting thespinal implant 100 into the disc space, or may be attached after thespinal implant 100 is positioned in the disc space. A slap hammer (notshown), as is known in the art, or other suitable instrument may be usedwith or integrated into the insertion instrument 200 or the insertionshaft 250 to facilitate placement of the spinal implant 100 into thedisc space.

In one embodiment, the driving instrument 300, which is positioned inthe height adjusting position “H”, is inserted through the lumen 201 ofthe insertion instrument 200. As shown, for example, in FIG. 17C, thedriving instrument 300 extends through the insertion instrument 200 suchthat the open tip 316 of the outer shaft 310 engages the flange nut 154of the spinal implant 100 and the distal tip 326 of the distal innershaft 320 engages the recessed proximal end 172 b of the threaded post172. The clinician may then move the adjustment knob 336 of the drivinginstrument 300 to posterior adjusting position “P” or the lordosisadjusting position “L”, as described above, to actively engage/disengagethe outer shaft 310 or the distal inner shaft 320 to adjust the position(i.e., height) of the proximal or distal region 100 a, 100 b of thespinal implant 100.

For example, as discussed above, the adjustment knob 336 of the drivinginstrument 300 may be moved to the posterior adjusting position “P” toactively engage the outer shaft 310 (and disengage the distal innershaft 320) such that rotation of the proximal outer shaft 332 in a firstor second direction rotates the flange nut 154 of the spinal implant 100which, in turn, actuates the proximal adjustment assembly 150 of thespinal implant 100. The adjustment knob 336 of the driving instrument300 may be moved to the lordosis adjusting position “L” to activelyengage the distal inner shaft 320 (and disengage the outer shaft 310)such that rotation of the proximal outer shaft 332 in a first or seconddirection rotates the threaded post 172 which, in turn, actuates thedistal adjustment assembly 170 of the spinal implant 100.

In another embodiment, the driving instrument 400 is inserted throughthe lumen 201 of the insertion instrument 200 such that the open tip 316of the outer shaft 310 engages the flange nut 154 of the spinal implant100 and the distal tip 326 of the distal inner shaft 320 engages therecessed proximal end 172 b of the threaded post 172. The clinician maythen rotate the inner shaft 420 to rotate both the outer and innershafts 410, 420 simultaneously which, in turn, actuates the proximal anddistal adjustment assemblies 150, 170 of the spinal implant 100 untilresistance is met by each of the outer and inner shafts 410, 420, asdescribed above, to adjust the position (e.g., the height) of theproximal and distal regions 100 a, 100 b of the spinal implant 100 withthe disc space.

It is envisioned that a feedback mechanism (e.g., audible, tactile,etc.) may be incorporated into the insertion instrument 200 and/or thedriving instrument 300, 400 to provide an indication to the clinician ofexpansion and/or retraction of the proximal and/or distal adjustmentassemblies 150, 170 of the spinal implant 100. For example, theinsertion instrument 200 and/or the driving instrument 300, 400 mayinclude a ratchet such that each turn, or portion of a turn, produces anaudible sound (e.g., a click) to alert the clinician that the spinalimplant 100 is being expanded and/or retracted. Further, each audibleclick may represent expansion or contraction of a predetermined amount(e.g., 2 mm). Additionally or alternatively, the insertion instrument200 and/or the driving instrument 300, 400 may include a quick releasefeature (e.g., that releases a ratchet) so that the surgical implant 100can be quickly reduced.

Various allograft and/or autograft materials may be placed into and/ornext to the spinal implant 100 to assist in the fusion process. By wayof example, it is contemplated that a catheter or similar tubularinstrument may be inserted through the lumen 201 of the insertioninstrument 200 after the insertion shaft 250 or the driving instrument300, 400 is removed. Bone or other natural or synthetic graft materialmay then be injected through the catheter or tubular instrument to exitat the far end of the instrument to provide graft material in and aroundthe spinal implant 100. Should the clinician need to adjust the proximaland/or distal heights of the spinal implant 100 once it is expanded, thedriving instrument 300, 400 would be re-engaged with the flange nut 154and/or the threaded post 172 for the desired adjustment.

While the embodiments shown and described herein illustrate systemsincluding either the driving instrument 300 or the driving instrument400, it should be understood that a method of adjusting the spinalimplant 100 may include the use of both driving instruments 300, 400.

For example, the spinal implant 100 attached to the insertion instrument200, and optionally the insertion shaft 250, may be inserted into a discspace between vertebrae with the exterior surfaces of the upper andlower bodies 110, 130 of the spinal implant 100 substantially parallel.The driving instrument 300 or the driving instrument 400 may then beused to actuate both the proximal and distal adjustment assemblies 150,170 of the spinal implant 100 such that the spinal implant 100 isexpanded while maintaining the upper and lower bodies 110, 130substantially parallel to one another until the vertebral bodies areengaged. Thereafter, the proximal and distal adjustment assemblies 150,170 may be individually actuated via the driving instrument 300 toadjust the disposition of the upper and lower bodies 110, 130 toaccommodate lordosis. Alternatively, after the spinal implant 100 isinserted into a disc space with the upper and lower bodies 110, 130substantially parallel, one of the proximal or distal regions 100 a, 100b of the spinal implant 100 may be expanded by actuating thecorresponding proximal or distal adjustment assembly 150, 170, followedby either (i) expanding the proximal and distal regions 100 a, 100 b ofthe spinal implant 100 simultaneously to provide further parallelexpansion, or (ii) expanding the other of the proximal or distaladjustment assembly 150, 170 to adjust the other region of the spinalimplant 100 into contact with the vertebral bodies. Thereafter, thespinal implant 100 may be (i) locked in place with the set screw 190 asdescribed below, (ii) further expanded or retracted in parallel byactuating the proximal and distal adjustment assemblies 150, 170 at thesame time, or (iii) further adjusted to conform to the anatomy byalternately actuating one or both of the proximal and distal adjustmentassemblies 150, 170.

It is further contemplated that the spinal implant 100 may be adjustedto approximate the lordosis of the patient by adjusting one or both ofthe proximal and distal adjustment assemblies 150, 170 prior toinserting the spinal implant 100 into the disc space, therebyapproximating the pre-existing lordotic condition of the patient. Afterthe spinal implant 100 is so adjusted and inserted, either of thedriving instruments 300, 400 may then be used to actuate the proximaland distal adjustment assemblies 150, 170 such that the spinal implant100 is expanded until the vertebral bodies are engaged. Thereafter, theproximal or distal adjustment assembly 150, 170 may be actuated toadjust the disposition of the upper and lower bodies 110, 130 of thespinal implant 100 to accommodate lordosis. Alternatively, after thespinal implant 100 is inserted with the upper and lower bodies 110, 130predisposed for lordosis, one of the proximal or distal regions 100 a,100 b of the spinal implant 100 may be expanded by actuating thecorresponding proximal or distal adjustment assembly 150, 170, followedby either (i) expanding the proximal and distal regions 150, 170 of thespinal implant 100 simultaneously, or (ii) expanding the other of theproximal or distal adjustment assembly 150, 170 to adjust the otherregion of the spinal implant 100 into contact with the vertebral bodies.Thereafter, the spinal implant 100 may be (i) locked in place with theset screw 190, (ii) further expanded or retracted in parallel byactuating the proximal and distal adjustment assemblies 150, 170 at thesame time, or (iii) further adjusted to conform to the anatomy byalternately actuating one or both of the proximal and distal adjustmentassemblies 150, 170.

As shown in FIG. 22, a system 6 includes the spinal implant 100, theinsertion instrument 200, and a set screw driver 500. The set screwdriver 500 includes an elongated body 502 having a proximal end 504configured to engage a rotation instrument (not shown, but which may bea T-handle) and a distal end 506 configured to engage the set screw 190(FIG. 1) of the spinal implant 100. In a method of use, the set screwdriver 500, having the set screw 190 releasably attached thereto, isintroduced through the lumen 201 of the insertion instrument 200 suchthat the set screw 190 may be screwed into the threaded inner surface153 (FIG. 3) of the linkage body 152 to lock the spinal implant 100 inthe desired position.

With reference now to FIGS. 23A-23C, an embodiment of a sleeve 600 foruse in a system of the present disclosure is shown. The sleeve 600includes an elongated sleeve body 602 extending along a longitudinalaxis “Z” and defining a channel 603 therethrough. The elongated sleevebody 602 has a proximal portion 602 a including a handle 604 extendingtherefrom in a direction that is transverse to the longitudinal axis “Z”and a distal portion 602 b sized and shaped for positioning betweenadjacent vertebral bodies to maintain the opening of a disc space. Theelongated sleeve body 602 is formed from a rigid biocompatible material,such as metals or metal alloys to provide stability to the sleeve 600,for example, during insertion into a disc space.

In a method of use, prior to the clinician placing the spinal implant100 into the disc space using the insertion instrument 200, theclinician inserts the distal end 602 b of the elongated sleeve body 602between the adjacent vertebral bodies to maintain the disc spacetherebetween. A slap hammer (not shown) or other suitable instrument maybe used to facilitate placement of the distal end 602 b of the sleeve600 therein. Thereafter, as shown in system 7 of FIGS. 24A-24C, theinsertion instrument 200 is inserted through the sleeve 600 by passingthe body portion 220 of the insertion instrument 200, which is attachedto the spinal implant 100, distally through the channel 603 (FIG. 23C)of the elongated sleeve body 602 until the elongated shaft 222 of theinsertion instrument 200 is positioned within the elongated sleeve body602 and the spinal implant 100 extends distally therefrom into the discspace. Once the spinal implant 100 is positioned in the disc space, theclinician continues with the procedure as discussed hereinabove.

Persons skilled in the art will understand that the structures andmethods specifically described herein and shown in the accompanyingfigures are non-limiting exemplary embodiments, and that thedescription, disclosure, and figures should be construed merely asexemplary of particular embodiments. By way of example, it iscontemplated that the insertion instrument and/or driving instrument maybe provided with indicia or other markings or references to indicate therelative position of the threaded post and/or flange nut, so that theposition of the upper and lower bodies relative to one another can beunderstood from the positon of the instrument handles. It is to beunderstood, therefore, that the present disclosure is not limited to theprecise embodiments described, and that various other changes andmodifications may be effected by one skilled in the art withoutdeparting from the scope or spirit of the disclosure. Additionally, theelements and features shown and described in connection with certainembodiments may be combined with the elements and features of certainother embodiments without departing from the scope of the presentdisclosure, and that such modifications and variation are also includedwithin the scope of the present disclosure. Accordingly, the subjectmatter of the present disclosure is not limited by what has beenparticularly shown and described.

What is claimed is:
 1. A driving instrument for adjusting a spinalimplant comprising: an outer shaft including a distal end; and an innershaft disposed within the outer shaft, the inner shaft including adistal end, the distal ends of the outer and inner shafts configured toactuate respective proximal and distal adjustment assemblies of a spinalimplant and a proximal end extending proximally from the outer shaft andconfigured to be rotated such that rotation of the inner shaft resultsin simultaneous rotation of the inner and outer shafts, wherein rotationof the outer shaft ceases at a first value of resistance associated withthe proximal adjustment assembly and rotation of the inner shaft ceasesat a second value of resistance associated with the distal adjustmentassembly, such that cessation of rotation of the inner shaft isindependent from cessation of rotation of the outer shaft.
 2. Thedriving instrument according to claim 1, wherein the distal end of theouter shaft has an inner surface configured to engage a drive nut of theproximal adjustment assembly, and the distal end of the inner shaftincludes an outer surface configured to engage a drive screw of thedistal adjustment assembly.
 3. The driving instrument according to claim1, wherein a bearing assembly is disposed around the inner shaft andwithin the outer shaft.
 4. The driving instrument according to claim 3,wherein the bearing assembly includes a bearing retainer having ballbearings disposed therein, and end plates positioned on opposed sides ofthe bearing retainer.
 5. The driving instrument according to claim 1,wherein a bushing is disposed around the inner shaft and within theouter shaft.
 6. The driving instrument according to claim 5, wherein aspring is disposed around the inner shaft and is partially disposedwithin the bushing.
 7. A system for implanting a spinal implant into adisc space between adjacent vertebral bodies, the system comprising: aspinal implant including proximal and distal adjustment assemblies thatare independently operable to change a height of a proximal or distalregion, respectively, of the spinal implant; and a driving instrumentcomprising: an outer shaft including a distal end configured to actuatethe proximal adjustment assembly of the spinal implant; and an innershaft disposed within the outer shaft, the inner shaft including adistal end configured to actuate the distal adjustment assembly of thespinal implant and a proximal end extending proximally from the outershaft and configured to be rotated such that rotation of the inner shaftresults in simultaneous rotation of the inner and outer shafts toactuate both the proximal and distal adjustment assemblies, whereinrotation of the outer shaft ceases at a first value of resistanceassociated with the proximal adjustment assembly and rotation of theinner shaft ceases at a second value of resistance associated with thedistal adjustment assembly such that cessation of rotation of the innershaft is independent from cessation of rotation of the outer shaft. 8.The system according to claim 7, wherein the distal end of the outershaft of the driving instrument has an inner surface configured toengage a drive nut of the proximal adjustment assembly, and the distalend of the inner shaft includes an outer surface configured to engage adrive screw of the distal adjustment assembly.
 9. The system accordingto claim 7, wherein a bearing assembly is disposed around the innershaft and within the outer shaft of the driving instrument.
 10. Thesystem according to claim 9, wherein the bearing assembly includes abearing retainer having ball bearings disposed therein, and end platespositioned on opposed sides of the bearing retainer.
 11. The systemaccording to claim 7, wherein a bushing is disposed around the innershaft and within the outer shaft of the driving instrument.
 12. Thesystem according to claim 11, wherein a spring is disposed around theinner shaft and is partially disposed within the bushing.
 13. The systemaccording to claim 7, further comprising: an insertion instrumentcomprising: a body portion defining a lumen therethrough configured forreception of the driving instrument therein such that the proximal endof the driving instrument extends proximally therefrom; and a connectorassembly including connector arms pivotably secured to opposed sides ofthe body portion, the connector arms configured to engage an outersurface of the spinal implant.
 14. The system according to claim 13,wherein the insertion instrument includes a handle having a buttondisposed therein, the button biased within the handle such that a slotdefined through the button is axially misaligned with the lumen of thebody portion, the button depressible to align the slot with the lumen.15. The system according to claim 13, further comprising: an insertionshaft positionable through the lumen defined through the insertioninstrument, the insertion shaft having a distal end configured to engagethe spinal implant.
 16. The system according to claim 13, furthercomprising: a set screw driver positionable through the lumen definedthrough the insertion instrument, the set screw driver having a distalend configured to releasably engage a set screw of the spinal implant.17. The system according to claim 13, further comprising: a sleeveincluding an elongated sleeve body defining a channel therethrough, thechannel dimensioned to receive the body portion of the insertioninstrument therethrough.